The U.S. Food and Drug Administration (FDA) announced today that AdenoPlus™ – an improved version of Rapid Pathogen Screening’s (RPS®) first point-of-care (POC) diagnostic test for conjunctivitis (pink eye) – has been granted waived status under the Clinical Laboratory Improvement Amendments (CLIA). Being granted this waiver classifies AdenoPlus as a low complexity device, which allows medical office personnel – not just a physician – to administer the test. Obtaining the CLIA waiver, in addition to the FDA 510(k) clearance that this next-generation product previously received, enables AdenoPlus to be used throughout the United States, an expansion from its current use in many international countries.
“The clinical signs and symptoms of Adenoviral and bacterial conjunctivitis are nonspecific, making it very challenging to diagnose clinically,” says Robert Sambursky, MD, RPS President and Chief Medical Officer. “AdenoPlus provides an accurate Adenovirus diagnosis in 10 minutes, positioning this test in the same category with other rapid and routinely used in-office diagnostic tools such as Strep and Flu tests.”
Due to the overlap in signs and symptoms, many healthcare providers empirically treat all cases of conjunctivitis with topical antibiotics, which are ineffective against the viral form of the infection. As a result, this can lead many patients to return to school, work, or daycare while still contagious. This overuse of antibiotics also contributes to the growing concern of increased resistance to antibiotics.
AdenoPlus allows for the rapid detection of Adenoviral antigens directly from human tears on the inside of the lower eyelid (conjunctiva). A nurse or technician can perform the test when a patient presents with a red eye or other symptoms of conjunctivitis. The patient can then be isolated while they wait only 10 minutes for the result. The speed and accuracy of the test result enables clinicians to make an accurate laboratory-quality diagnosis and provide the appropriate treatment plan before the patient leaves the office, reducing the spread of disease.
AdenoPlus has greater analytical sensitivity than the first generation test and demonstrates a clinical sensitivity of 90 percent and a specificity of 96 percent when compared against cell culture – the gold standard – as the reference method. This level of accuracy allows for the initiation of appropriate patient management at the office visit and reduces future unnecessary medical office visits, the cost of ineffective antibiotic prescriptions, and the need for additional laboratory testing, resulting in healthcare cost savings of hundreds of millions of dollars per year.